eligibility_summary
Adults 18–80 with SLE (2019 EULAR/ACR) and proliferative LN (Class III/IV ±V) by biopsy ≤6 mo, ANA≥1:80 or +anti‑dsDNA/anti‑Sm, 24‑h UPCR ≥113.17 mg/mmol, eGFR ≥35, negative pregnancy test if applicable, consent/compliance. Exclude: mAb/IG allergy, MMF intolerance, pure Class V, dialysis in 12 mo/expected RRT, other renal disease, immunodeficiency/HIV, HBV/HCV/TB/herpes/active infection, recent cardiac disease, cancer ≤5 y, live vaccine ≤4 wks, recent IS/biologics/DMARDs.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Drug/intervention: Daxdilimab (HZN-7734), a human afucosylated IgG1 monoclonal antibody given subcutaneously, comparator: placebo, both on top of MMF + corticosteroids. Mechanism of action: Binds ILT7 (LILRA4) on plasmacytoid dendritic cells (pDCs) and depletes them via enhanced ADCC, lowering pDC-derived type I interferons (IFN-α/β) and interferon-stimulated gene signaling. Cells/pathways targeted: pDCs, ILT7 receptor, the TLR7/9–pDC–type I IFN axis, downstream B-cell activation, autoantibody production, and kidney inflammatory pathways relevant to proliferative lupus nephritis. Trial: Phase 2, randomized, double-blind, placebo-controlled, status terminated (sponsor decision).